Manager, Regulatory Affairs
Manager, Regulatory Affairs
South Africa - Johannesburg
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
We have an exciting opportunity for a Regulatory Affairs Manager and Deputy Responsible Pharmacist in the South African Affiliate. This role will be based in Johannesburg, South Africa.
The RA Manager is responsible for ensuring that Gileads medicinal products in his/her responsibility can be developed, authorized and maintained on the market, in compliance with the country's applicable legislations and regulations. This role requires cross-functional partnerships locally and internationally, to ensure that all projects have the appropriate local regulatory input and guidance.
The ideal candidate has a solid expertise in the regulatory affairs area in South Africa along with a positive, proactive and innovative mindset.
ROLES AND RESPONSIBILITIES
- Act as Deputy Responsible Pharmacist for Gilead Sciences South Africa in line with the Pharmacy Act. Provide the duties and support required of a Regulatory Affairs function on behalf of Gilead. Work is performed under consultative direction towards corporate regulatory goals and objectives.
- Supports the regulatory strategy and manages the preparation / evaluation of all required documentation for NDAs and line extensions (including Clinical trials).
- Manages the regulatory maintenance for the current portfolio, including annual reports, labeling updates and variations. Interacts closely with other functions/stakeholders in the organization to ensure that the regulatory strategy is robust and agreed, and any required submissions are executed within the specified timeframes.
- Monitors regulations and changes in regulatory environment in order to keep internal stakeholders aware of risks and opportunities in a timely manner.
- Interacts with HA and trade associations representing Gilead as necessary.
- Supports maintenance of GMP license and Quality Agreements, as required.
- Supports the management of the Quality Management System of the Affiliate and the maintenance of all SOPs and associated documentation as required. This includes the management of change controls, deviations and the CAPA process in the local Affiliate.
- Initiates or supports local process improvements and contributes to local and/or global process improvements which have a significant impact for RA and other departments, assesses proposed changes to local procedural documents and impact on existing processes.
- Manages the artwork.
- Supports Clinical Trial Applications where required.
- Reviews and approves promotional and non-promotional materials in accordance with local regulations, Gileads business conduct and South African Marketing Code
- Acts as deputy responsible person for pharmacovigilance.
EDUCATION and EXPERIENCE
- B.Pharm and registration with the South African Pharmacy Council as a Pharmacist
- Experience in South Africa Regulatory Affairs.
- Extensive knowledge of local regulations
- A proven ability to co-ordinate the preparation of a variety of complex regulatory documentation in collaboration with other functions.
- Excellent communication skills both in writing and verbally
- Quality Management and Pharmacovigilance experience is an advantage.
Gilead Core Values
- Integrity (Doing What's Right),
- Teamwork (Working Together),
- Excellence (Being Your Best)
- Accountability (Taking Personal Responsibility).
- Inclusion (Encouraging Diversity)
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
For more information please visit Gilead.com
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/South-Africa---Johannesburg/Manager--Regulatory-Affairs_R0016933-2
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